PMA P190018S044
- Device
- Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S044
- Product code
- HQL
- Decision date
- 2025-09-18
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- automation of the wafer welding and assembly process for Clareon IOLs
Current openFDA PMA Record#
- Device
- Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon® Toric Aspheric Hydrophobic Acrylic Intraocular Le
- Applicant
- Alcon Laboratories, LLC
- PMA number
- P190018
- Supplement
- S044
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-09-18
- Decision code
- OK30
- Date received
- 2025-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of the wafer welding and assembly process for Clareon IOLs